Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction (NCT04243265) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study Relating to Patients Undergoing Medial Femoral Patellar Ligament Reconstruction
Italy17 participantsStarted 2015-12-17
Plain-language summary
The objective of the present study will be to evaluate the clinical patellofemoral joint function (primary endpoint) and radiographically the patellofemoral arthritic degeneration (secondary endpoint) of of MPFL reconstruction with fascia lata allograft at a minimum follow-up of 2, 5 and 10 years in a group of 25 patients.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* The potential person is of legal age, capable of providing informed consent and must sign the Informed Consent Form approved by the Ethics Committee (EC).
* Diagnosis of MPFL injury, performed before surgery, documented by Magnetic Resonance Imaging (MRI) of the affected knee.
* Absence of osteochondral lesions larger than 3 cm2 at the baseline.
* The contralateral knee was and is asymptomatic, stable and functional.
* The patient must be physically and mentally inclined and must have completed post-operative rehabilitation according to the protocol provided at the time of discharge.
Exclusion Criteria:
* Local or systemic infection
* Knee osteoarthritis documented radiographically at baseline
* Articular cartilage injury greater than grade I of Outerbridge detected during surgery.
* History of anaphylactic reaction.
* Systemic therapy with all types of corticosteroids or immunosuppressants in the 30 days prior to surgery.
* Evidence of osteonecrosis in the involved knee.
* History of rheumatoid arthritis, inflammatory arthritis or autoimmune pathologies.
* Neurological pathologies or conditions that the patient is unsuitable for the rehabilitation protocol.
* Untreated meniscal tissue loss greater than 50% at baseline.
* State of pregnancy.
* Obese or with body mass index BMI\> 30 kg / m2.
* Association of Trocleoplasty (intervention that produces degenerative changes in the joint in high apercent).
What they're measuring
1
Visual Analogue Scale
Timeframe: 120 months
2
Short-Form 12
Timeframe: 120 months
3
Kujala knee Score
Timeframe: 120 months
4
Level of Tegner activity
Timeframe: 120 months
5
Objective evaluation of the International Knee Documentation Committee